Esokalli Testosterone Booster Oral Dissolving Film Liquid
FDA Label NDC 84778-079

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yixin Cross-border E-commerce Co., Ltd. for the product Esokalli Testosterone Booster Oral Dissolving Film (NDC 84778-079). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each film), purpose, uses, warnings, dosage and administration, do not use, when using this product you may experience:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Film)

→ Purpose

→ Uses

→ Warnings

→ Dosage And Administration

→ Do Not Use

→ When Using This Product You May Experience:

→ Stop Use And Ask A Doctor If:

→ Contraindications

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredients (In Each Film)

Tadalafil 20 mg – Erectile dysfunction treatment
Vardenafil 20 mg – Erectile dysfunction treatment

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

Uses

For the treatment of erectile dysfunction (ED)

Warnings

For prescription use only (Rx only).

Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension.
Do not use if allergic to tadalafil, vardenafil, or any component of this product.

Dosage And Administration

For external use only.

Do Not Use

heart problems, history of heart attack, irregular heartbeat, or chest pain
high or low blood pressure
liver or kidney disease
vision or hearing problems
history of priapism (painful or prolonged erection lasting >4 hours)